Kornimate/medical-research-clean huggingface dataset:
growth trial: study of the renata minima stent

Conditions: Coarctation of the Aorta; Pulmonary Artery Stenosis

Summary: the objective of the clinical investigation is to access clinical safety and effectiveness of the minima stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.


Eligibility criteria:
inclusion criteria include: * the subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent * requiring treatment\* of: * native, acquired, or recurrent aortic coarctation, or * native, acquired, or recurrent pulmonary artery stenosis \*as defined by the patient's medical team * patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system * adjacent vessel to stenosis measuring \> or equal to 4 mm exclusion criteria include: * active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation * history of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation * aortic or pulmonary artery aneurysm in the location targeted for treatment * body weight \< 1.5 kg * anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent * target vessels larger or smaller than the minima system balloon size ranges * known genetic syndrome known to be associated with vasculopathies such as but not limited to williams syndrome, loeys-dietz syndrome, etc * clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure. * currently participating in an investigational drug study or another device study * major or progressive non-cardiac disease resulting in a life expectancy of less than six months * known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications * known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately pre-medicated
infant feeding, non-nutritive sucking and speech development

Conditions: Speech Disorders in Children

Summary: this study will look at whether there is a relationship between how babies are fed, whether they suck a dummy/hand and how they develop speech.

background: in the uk every year around 48,000 children aged 2-5 years are referred to nhs speech \& language therapy (slt) services with difficulties using the right sounds in their talking. this is known as speech sound disorders (ssd). this is the largest population seen by speech and language therapists and costs the nhs about £24 million per year. children with ssd are more at risk of mental health problems and difficulties making relationships with those around them. they are also more likely to struggle with learning at school and be involved with the criminal justice system at some point in their early lives. when a baby is born parents make different choices about feeding their baby. some breastfeed, some bottle-feed and some use a mixture of both. some babies also like to have a dummy, while others suck their hand and some don't suck anything. some studies have found that breastfeeding is linked to better language and learning in later childhood, while others have found that dummy sucking has the opposite effect. however, the effect that different types of feeding have on speech development has not been looked at in as much detail.

Eligibility criteria:
inclusion criteria: * children aged 2;0-5;6 on current speech and language therapy clinical caseloads in hampshire (solent nhs trust) who have a diagnosis of speech sound disorder. exclusion criteria: * genetic disorder (including downs syndrome and other identified syndromes) other congenital anomaly (e.g cerebral palsy, global developmental delay) diagnosed learning disability permanent hearing loss (sensorineural) cleft lip and/or palate and/or submucous cleft palate premature birth (before 37 completed weeks gestation) english as second or additional language

Keywords: speech disorder breast feeding infant feeding bottle feeding speech development speech sound development speech sound disorder non-nutritive sucking
a study to evaluate the efficacy and safety of arbaclofen placarbil (xp19986) as adjunctive therapy in subjects with gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of the study is to evaluate efficacy and safety of arbaclofen placarbil (xp19986) versus placebo as adjunctive therapy in subjects with troublesome gerd symptoms despite therapy with approved doses of a proton pump inhibitor (ppi).


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of gerd by a gastroenterologist 2. minimum of 3 months of gerd symptoms prior to screening. 3. currently taking an fda approved dose of ppi therapy for symptomatic gerd for at least 4 weeks prior to screening 4. experienced partial relief of gerd symptoms while receiving approved dose and regimen of ppi therapy 5. experienced gerd symptoms, defined as heartburn (with or without regurgitation or other gerd symptoms) on ≥ 3 days during the week prior to screening exclusion criteria: 1. evidence of erosive esophagitis or erosive gastritis on upper gastrointestinal endoscopy during screening 2. has not experienced any gerd symptom improvement after an adequate course of ppi treatment (at least 2 weeks) 3. unstable or severe medical condition

Keywords: gerd
piloting virtual reality environments to treat ptsd in healthcare workers

Conditions: Posttraumatic Stress Disorder

Summary: healthcare workers and covid-19 patients may experience psychological distress consequent to the pandemic, and are at particularly elevated risk for experiencing posttraumatic stress disorder (ptsd), based on evidence from previous infectious disease outbreaks. the best-validated treatment for ptsd is exposure therapy. exposure therapy help patients suffering from ptsd to revisit and overcome their traumatic experiences. including virtual reality in exposure therapy has a long history in treating ptsd; and has been used to treat military veterans and first-responders following 9/11. the investigators are developing and testing a virtual environment to treat ptsd including sub threshold ptsd symptoms in hcws who experience occupational related trauma (e.g., working with covid-19 patients) and covid-19 patients. an independent evaluator will assess symptoms of ptsd and other psychopathology, using structured clinical interviews and self-report measures with well-established psychometric properties, at baseline, halfway through treatment, after completion of treatment, and at three-months post-treatment. participants will complete ten ninety minute sessions (in-person or remotely), twice a week for five weeks aimed at mitigating their symptoms of ptsd. remote participants will receive vr headsets after the baseline assessment and will keep them for the duration of the study. the pilot study will aim to demonstrate the feasibility and the tolerability of the virtual reality intervention in these populations.


Eligibility criteria:
inclusion criteria: * a covid-19 patient or any healthcare worker providing medical care or support who experiences occupational-related trauma * english-speaking * age ≥18 * medically stable * diagnosed with ptsd or sub threshold ptsd * ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments * stable on psychotropic medication for the prior 60 days exclusion criteria: * current significant unstable medical illness such that the participant could not attend sessions regularly or complete assessments * patients who in the investigator's judgment pose a current homicidal, suicidal or other risk * lifetime or current diagnosis of schizophrenia or other psychotic disorder * participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or ptsd during the previous 3 months * history of motion sickness or seizures

Keywords: ptsd virtual reality vr healthcare workers covid-19 pandemic
a study of bgm0504 in participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this trial is conducted in china. the aim of the trial is to evaluate the efficacy and safety of bgm0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * ■ have been diagnosed with type 2 diabetes mellitus (t2dm); * metformin is used in screening : 1) after used stable-dose metformin (≥1500 mg/day) or maximum tolerated (\< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)metformin treatment dose \<1500mg/day at screening and have not reached the maximum tolerated dose ；3) metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period. * have a bmi ≥23 kilograms per meter squared (kg/m²) at screening; * be of stable weight (± 5%) for at least 3 months before screening; * have hba1c between ≥7.5% and ≤11.0%； exclusion criteria: * ■ previous diagnosis of type 1 diabetes, special type diabetes; * there are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery). * have had chronic or acute pancreatitis any time prior to study entry; * known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to glp-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening; * mentally incapacitated or speech-impaired; * suspected or confirmed history of alcohol or drug abuse; * pregnant or lactating woman; * the investigator considers that there are any other conditions that make it inappropriate to participate in this study.
dose escalation and expansion study of hm16390 in advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: this is a first-in-human, phase 1, dose-escalation and dose-expansion study of hm16390, as a single agent to assess safety, tolerability, mtd, rp2d, pk, and efficacy in patients with advanced or metastatic solid tumors. dose-escalation part is planned to establish the mtd or rds for the randomized dose-ranging part. based on the results of the dose-escalation part, additional eligible subjects will be randomized 1:1 into at each dose level. after a comprehensive review of available data from both dose-escalation part and dose-ranging part, the potential rp2d to be tested in the dose-expansion part is determined. dose-expansion part is designed to assess the potential efficacy of hm16390 as a single agent when administered at the potential rp2d to subjects in indication-specific expansion cohorts.


Eligibility criteria:
key inclusion criteria: * have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit. * patients in the dose-escalation part must have evaluable or measurable disease at baseline and the patients for dose-ranging and dose-expansion part must have at least one measurable lesion at baseline by computed tomography (ct) or magnetic resonance imaging (mri) per response evaluation criteria in solid tumors (recist) v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * age of 18 years or older (or country's legal age of majority if the legal age was \>18 years) * adequate renal function. * adequate hematologic function. * adequate liver function. key exclusion criteria: * received prior treatment with agent targeting the il-2, il-7, or il-15 receptors, or related to mode of action of hm16390. * known active cns metastases and/or carcinomatous meningitis. * history of severe toxicities associated with a prior immunotherapy. * any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to grade ≤ 1 per ctcae version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment. * has ongoing or suspected autoimmune disease. * known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (hiv) or acquired immunodeficiency syndrome (aids)-related illness, immunocompromised patients. * history of chronic liver disease or evidence of hepatic cirrhosis.
safety and efficacy of pimecrolimus cream 1% in mild to moderate head and neck atopic dermatitis (ad) patients

Conditions: Atopic Dermatitis

Summary: this study is not being conducted in the united states. patients who are intolerant of topical corticosteroids (tcs) have either experienced an adverse event resulting from the use of tcs, or require unacceptable levels of exposure to tcs in order to control their ad. this is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck. the purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck ad in patients who are intolerant of, or dependent on topical corticosteroids.


Eligibility criteria:
inclusion criteria: * 12 years of age or older * mild to moderate facial ad at screening (facial iga 2 - 3) * patients intolerant of, or dependent on, topical corticosteroids * diagnosis of atopic dermatitis by the hanifin and rajka criteria * for female patients, a negative pregnancy test. women who are pregnant or who are breast-feeding may not be included in the study. women of child-bearing potential must follow a medically recognized form of contraception. exclusion criteria: at baseline and throughout the study, patients: * who have ad on greater than 30% of total body surface area in addition to facial eczema * who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, netherton's syndrome) * who are immunocompromised (e.g. lymphoma, aids, wiskott-aldrich syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma) * who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (elidel) * who have received phototherapy (e.g. uva, uvb) or systemic therapy (e.g.immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on ad within 4 weeks of visit 2 * who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study * who are unlikely to comply with therapy

Keywords: atopic dermatitis pimecrolimus
efficacy and safety of navio

Conditions: Osteoarthritis, Knee

Summary: the goal of the study is to compare the efficacy, safety and costs of the navio™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. the hypothesis is that total knee arthroplasty (tka) with the use of navio™ is at least as efficient and safe as tka with the use of conventional intramedullary alignment guiding.


Eligibility criteria:
inclusion criteria: * painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by x-ray * high need to obtain pain relief and improve function * above 18 years old * able and willing to follow instructions * informed consent exclusion criteria: * active infection in knee * general infection * failure of previous joint replacement * post-operative or post traumatic malalignment of the knee/leg * pregnancy * not able or willing to undergo ct-scan
biodistribution, pharmacokinetics, and safety of f-18 thk-5351 pet in alzheimer's disease patients and healthy subjects.(positron emission tomograph )

Conditions: Alzheimer's Disease

Summary: biodistribution, pharmacokinetics, and safety of f-18 thk-5351 pet in alzheimer's disease patients and healthy subjects.

totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably alzheimer's dementia patients with nincds-adrda criteria. for disease subjects, caregiver should be able to report activities of daily living and their mental status. patient should be able to give informed consent or have a caregiver give consent with subject assent.

Eligibility criteria:
healthy inclusion criteria: * neurologic testing. (mmse 24-30, wechsler logical memory score \>5). * subjects must provide written inform consent. patients with ad inclusion criteria: * diagnosis of ad according to the clinical diagnostic criteria of "possible ad" with nincds-adrda criteria * mmse 20-26, clinical dementia rating 0.5 or 1, wechsler logical memory score\<=4 * patient who provide a written informed consent prior to study entry. (if the patient is incapable informed consent, the caregiver may consent on behalf of the patient. the caregiver should be able to report activities of daily living and their mental status.) exclusion criteria: * pregnant or become pregnant * current breast feeding * clinically significant abnormal laboratory values * unstable medical or psychiatric illness. * cardiovascular disease (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease). * history of drug or alcohol abuse within the last year, or prior prolonged history of abuse. --history of severe allergic or anaphylactic reactions particularly to the tested drugs . * pi assessment with high risk.

Keywords: f-18 thk-5351 pet
diabetes attitudes wishes and needs

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Relatives to/Carers of Patients; Healthcare Professionals

Summary: the study is conducted in africa, asia, europe, japan, north america and south america. the multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.


Eligibility criteria:
inclusion criteria: * adults aged at least 18 years with diabetes (type 1 or type 2: not only during pregnancy) * adults aged at least 18 years involved in the daily care of an adult (18 years or older) with diabetes (type 1 or type 2) * general practitioners who personally treat at least 5 adults (18 years or older) with diabetes per month and initiate oral medication * diabetes specialists (endocrinologists/diabetologists) who personally treat at least 50 adults (18 years or older) with diabetes per month and prescribe oral medication, insulin or other injectable diabetes medications * diabetes educators (diabetes nurses/dieticians/other non-physician healthcare professionals) providing care for at least 5 adults (18 years or older) with diabetes per month * participants must have access to the internet, either at home or at a location convenient to them, or be able to attend a face-to-face or telephone interview, to participate in the survey * provision of informed consent before the start of any study-related activities exclusion criteria: * individuals aged below 18 years and/or diagnosed with diabetes less than 12 months ago * inability to understand and comply with written and verbal instructions
effect of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women

Conditions: Breast Cancer; Healthy, no Evidence of Disease

Summary: rationale: chemoprevention is the use of certain drugs to keep cancer from forming. eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming. purpose: this randomized phase iii trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women.

objectives: * examine the effects of two daily servings of soy on estrogen levels in nipple aspirate fluid (naf) and serum. * investigate cytologic patterns of epithelial breast cells obtained from naf as a measure of proliferation in relation to soy intake. * explore the effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites. * compare estrogen levels in naf and serum measured at the same time during the luteal phase. outline: this is a multicenter study. participants are randomized to 1 of 2 intervention arms. * arm i: participants partake in a high soy diet consisting of 2 daily soy servings (approximately 50mg isoflavones). the choice of soy foods will include ½ cup of tofu, ¾ cup of soy milk, or ¼ cup of soy nuts. replacement of currently consumed foods with soy foods will be encouraged. * arm ii: participants will be asked to keep their soy intake below 3 servings per week. the participants will also receive general nutrition counseling. in both arms, intervention continues for 6 months. after 6 months, participants undergo a 1-month washout period and then cross-over to the other intervention arm. nipple aspirate fluid, urine, and blood samples are collected periodically to measure laboratory endpoints.

Eligibility criteria:
disease characteristics: * healthy participant * no diagnosis of cancer patient characteristics: * premenopausal * regular menstrual cycles prior concurrent therapy: * not taking birth control pills or other hormones

Keywords: breast cancer healthy, no evidence of disease
risk screening and assessment of shoulder, neck and lower back discomfort.

Conditions: Low Back Pain; Neck Pain; Shoulder Pain

Summary: identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.

the purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. the body parameters (bmi, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.

Eligibility criteria:
inclusion criteria * 20-40 year of age with symptoms of shoulder * neck and lower back discomfort exclusion criteria * red flag sign of the neck